Liquichek - Liquichek Reticulocyte Control (X) Level 3 (An - BIO-RAD LABORATORIES, INC.

Duns Number:051624070

Device Description: Liquichek Reticulocyte Control (X) Level 3 (An assayed reticulocyte control.)

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More Product Details

Catalog Number

928

Brand Name

Liquichek

Version/Model Number

928

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K100050

Product Code Details

Product Code

JPK

Product Code Name

MIXTURE, HEMATOLOGY QUALITY CONTROL

Device Record Status

Public Device Record Key

a6b60c63-6ffb-416a-9525-341d68af150b

Public Version Date

January 23, 2020

Public Version Number

4

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIO-RAD LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 511
2 A medical device with a moderate to high risk that requires special controls. 428
U Unclassified 1